NCT06749457

A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)

A Phase I/IIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Participants and in Patients With End-stage Kidney Disease Receiving Hemodialysis Through a Central Venous Catheter

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).

Detailed description

In the Phase I portion of the study, participants will be randomized to receive one of 3 dosages of AZD7760 or placebo as a single intravenous infusion. Study details include: * A 28-day Screening Period. * A Dosing Period of 3 days in which a single intravenous infusion will be given on Day 1. * A Follow-up Period of 12 months from the time of administration of the study intervention. In the Phase IIa portion of the study, participants will be randomized to receive either AZD7760 or placebo as 2 intravenous infusions given 3 months apart. Study details include: * A 28-day Screening Period. * A Dosing Period in which 2 intravenous infusions will be given 3 months apart (Day 1 and Day 91). * A Follow-up Period of 12 months after the last administration of the study intervention on Day 91.

Conditions

• Staphylococcus Aureus

Interventions

Type	Name	Description
DRUG	AZD7760	Participants will receive AZD7760 as a single intravenous infusion.
OTHER	Placebo	Participants will be administered placebo through intravenous infusion.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-11-30
• Completion: 2027-09-09
• First posted: 2024-12-27
• Last updated: 2026-04-06

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study